Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia

Differences in Parental Caregiving Demands in Childhood Acute Lymphoblastic Leukemia by Length of Infusion Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00056069

Enrollment

172

Registered

2003-03-07

Start date

2002-12-31

Completion date

2010-03-31

Last updated

2015-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

psychosocial effects of cancer and its treatment, childhood acute lymphoblastic leukemia

Brief summary

RATIONALE: Studying the physical and emotional needs of parents who are caring for children receiving chemotherapy for cancer may help doctors plan effective treatments for the patient that allow for improved quality of life of the patient's family. PURPOSE: This clinical trial is studying the different physical and emotional needs of parents whose children are undergoing chemotherapy for acute lymphoblastic leukemia either in an outpatient clinic or in the hospital.

Detailed description

OBJECTIVES: * Compare the caregiving demands reported by parents of children with acute lymphoblastic leukemia receiving methotrexate on 2 different infusion schedules (inpatient care vs outpatient care). * Compare the change in caregiving demands on these parents over time, in terms of physical and emotional care, the need to make family arrangements, the need to communicate about the child's care, the need to gather information about the child's health status, and the effect on family well-being. OUTLINE: Participants complete questionnaires regarding caregiver demands and family information over 25-30 minutes within 3-4 months of the initiation of the child's treatment and at the completion of the first year of the child's treatment. PROJECTED ACCRUAL: A total of 164 participants will be accrued for this study within 0.8 years.

Interventions

OTHERquestionnaire administration

Participants complete questionnaires regarding caregiver demands and family information over 25-30 minutes within 3-4 months of the initiation of the child's treatment and at the completion of the first year of the child's treatment.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Parent or legal guardian who is the primary caregiver of a patient enrolled on COG-P9904 or COG-P9905 protocol * Patient has not yet received week 13 of therapy PATIENT CHARACTERISTICS: Age * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Able to understand English PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Design outcomes

Primary

Measure	Time frame
Event Free Survival	Length of study

Secondary

Measure	Time frame
Determine whether caregivers whose child is randomized to receive the 24-hour methotrexate infusion will report lower caregiving demand than will caregivers whose child is randomized to receive the 4-hour infusion	Length of study
Total score from the CMCC	Length of study

Countries

Australia, Canada, Netherlands, Puerto Rico, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026